BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET MICROBORE W/CAPPED CASSETTE PORTS AND CLAVE

    MDR report key: 1030671 · Received April 15, 2008

    Report

    Report Number
    9615050-2008-00096
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 28, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K12338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER STEM CELLS. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THE TUBING SEPARATED FROM THE LOWER CLAVE Y-SITE. IT WAS REPORTED THAT APPROXIMATELY 25ML OF STEM CELLS LEAKED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET MICROBORE W/CAPPED CASSETTE PORTS AND CLAVE 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1